Early Maladaptative Schemas Among Euthymic Patients With Bipolar Disorder in the Versailles FondaMental Advanced Centers of Expertise for Bipolar Disorders Cohort

Bipolar Disorder Clinical Trial

— SPIBIP  

Official title:

Early Maladaptative Schemas Among Euthymic Patients With Bipolar Disorder: Exploring the Relationships With Symptoms, Functioning and Cognition in the Versailles FondaMental Advanced Centers of Expertise for Bipolar Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03977909
• Other study ID #: CHVersailles
• Status: Recruiting
• Start date: July 1, 2009
• Est. completion date: December 1, 2024

Study information

• Verified date: August 2023
• Source: Versailles Hospital
• Contact: Paul ROUX, MD PhD
• Phone: +33139638310
• Email: paul.roux[@]uvsq.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Early Maladaptive Schemas (EMS) are overactivated in euthymic bipolar disorders (BD) and are associated with poor psychosocial functioning and higher suicidality.

The first objective of this study is to establish different clusters of EMS in euthymic bipolar disorders, compare these clusters according to the clinical characteristics of BD and neuropsychological performances and evaluate the temporal stability of these clusters at 12 and 24 months.

The second objective of this study is to quantify the impact of EMS on functioning in euthymic BD, beyond the effect of cognition and residual depressive symptoms.

Description:

Early Maladaptive Schemas (EMS) are overactivated in euthymic bipolar disorders (BD) and are associated with poor psychosocial functioning and higher suicidality. However, few studies have explored EMS in bipolar disorders, despite EMS therapy is a promising tool for the psychotherapy of BD.

This study will use the data collected at the Versailles Expert Center for Bipolar disorder, in the local FACE-BD registry. These data will be collected at the inclusion, 12 months and 24 months later. They included an extensive neuropsychological battery and an extensive evaluation of the clinical characteristics of bipolar disorder. EMS will be measured with the Young Schema Questionnaire Short Form 3.

The first objective of this study is to establish different clusters of EMS in euthymic bipolar disorders, compare these clusters according to the clinical characteristics of BD and neuropsychological performances and evaluate the temporal stability of these clusters at 12 and 24 months.

The second objective of this study is to quantify the impact of EMS on functioning in euthymic BD, beyond the effect of cognition and residual depressive symptoms.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• bipolar disorder according to DSM IV-R (structured clinical interview)

Exclusion Criteria:

• major depressive or manic or hypomanic during the evaluation

• Montgomery Åsberg Depression Rating Scale ?10

• Young Mania Rating Scale ?12

Related Conditions & MeSH terms

• Bipolar Disorder

Locations

Country	Name	City	State
France	Paul ROUX	Le Chesnay

Sponsors (4)

Lead Sponsor	Collaborator
Versailles Hospital	Fondation FondaMental, University of Bordeaux, Versailles Saint-Quentin-en-Yvelines University

Country where clinical trial is conducted

France, 

References & Publications (8)

Ball J, Mitchell P, Malhi G, Skillecorn A, Smith M. Schema-focused cognitive therapy for bipolar disorder: reducing vulnerability to relapse through attitudinal change. Aust N Z J Psychiatry. 2003 Feb;37(1):41-8. doi: 10.1046/j.1440-1614.2003.01098.x. — View Citation

Hawke LD, Provencher MD, Parikh SV. Schema therapy for bipolar disorder: a conceptual model and future directions. J Affect Disord. 2013 May 15;148(1):118-22. doi: 10.1016/j.jad.2012.10.034. Epub 2012 Dec 4. — View Citation

Morriss R. Clinical importance of inter-episode symptoms in patients with bipolar affective disorder. J Affect Disord. 2002 Dec;72 Suppl 1:S3-13. doi: 10.1016/s0165-0327(02)00340-3. — View Citation

Nilsson KK. Early maladaptive schemas and functional impairment in remitted bipolar disorder patients. J Behav Ther Exp Psychiatry. 2012 Dec;43(4):1104-8. doi: 10.1016/j.jbtep.2012.05.005. Epub 2012 Jun 7. — View Citation

Roux P, Raust A, Cannavo AS, Aubin V, Aouizerate B, Azorin JM, Bellivier F, Belzeaux R, Bougerol T, Cussac I, Courtet P, Etain B, Gard S, Job S, Kahn JP, Leboyer M, Olie E; FondaMental Advanced Centers of Expertise in Bipolar Disorders (FACE-BD) Collaborators; Henry C, Passerieux C. Associations between residual depressive symptoms, cognition, and functioning in patients with euthymic bipolar disorder: results from the FACE-BD cohort. Br J Psychiatry. 2017 Dec;211(6):381-387. doi: 10.1192/bjp.bp.117.201335. Epub 2017 Oct 19. — View Citation

Urosevic S, Abramson LY, Harmon-Jones E, Alloy LB. Dysregulation of the behavioral approach system (BAS) in bipolar spectrum disorders: review of theory and evidence. Clin Psychol Rev. 2008 Oct;28(7):1188-205. doi: 10.1016/j.cpr.2008.04.004. Epub 2008 May 9. — View Citation

Young, J. E., & Brown, G. (1998). Young schema questionnaire short form. New York: Cognitive Therapy Center.

Young, J. E., Klosko, J. S., & Weishaar, M. E. (2003). Schema therapy: A practitioner's guide, Guilford Press.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early Maladaptative Schemas T0	distance to the norm for the scores on each 18 early maladaptative schema measured with the Young Shema Questionnaire short form 3, no lower bound limit, no upper bound limit, a low score indicate a lower activation of the Early Maladaptative Schema	18 measures by subject, assessed at inclusion
Primary	Early Maladaptative Schemas T12	distance to the norm for the scores on each 18 early maladaptative schema measured with the Young Shema Questionnaire short form 3, no lower bound limit, no upper bound limit, a low score indicate a lower activation of the Early Maladaptative Schema	18 measures by subject, assessed at 12 months
Primary	Early Maladaptative Schemas T24	distance to the norm for the scores on each 18 early maladaptative schema measured with the Young Shema Questionnaire short form 3, no lower bound limit, no upper bound limit, a low score indicate a lower activation of the Early Maladaptative Schema	18 measures by subject, assessed at inclusion 24 months
Secondary	functioning	total score on the Functioning Assessment Short Test (lower bound 0 upper bound 72, lower scores indicates better functioning)	one measure by subject, assessed 3 times (inclusion, 12 months and 24 months)
Secondary	Depression	total score on the Montgomery Åsberg Depression Rating Scale (minimum 0 maximum 10)	one measure by subject, assessed 3 times (inclusion, 12 months and 24 months)
Secondary	Cognition	distance to the norm for the scores for each the five cognitive dimension measured with the standardised neuropsychological battery, no lower bound limit, no upper bound limit, lower scores indicate poorer cognition	5 measures by subject, assessed 2 times (at inclusion and 24 months)
Secondary	Hypomania	total score on the Young Mania Rating Scale (lower bound 0 upper bound 12, lower scores indicate lower hypomania	one measure by subject, assessed 3 times (inclusion, 12 months and 24 months)